Optimizing Biopharma Manufacturing: Innovations for Driving Excellence

The biopharmaceutical (biopharma) industry has experienced a remarkable evolution in the past decade, revolutionizing the landscape of manufactured and sold products. Today’s global biopharmaceutical portfolio encompasses a diverse range of therapies characterized by heightened therapeutic competition, and a rise in large-molecule drugs.

An expansion of personalized and targeted products, and an increased focus on treatments for orphan diseases. Let’s delve into the latest developments and cutting-edge innovations in biopharma manufacturing, exploring how these advancements are propelling excellence within the industry.

Understanding Biopharma Manufacturing

Biopharmaceutical manufacturing is a dynamic field characterized by advanced technologies, groundbreaking scientific discoveries, and intricate research and development (R&D) ventures. The process of developing a novel compound in this industry entails significant investments of time and capital to translate scientific breakthroughs into innovative medicines and establish specialized manufacturing facilities and equipment.

Initially, the production of investigational compounds for clinical trials requires the creation of initial supplies, followed by scaling up to full-scale production upon obtaining approval from regulatory authorities such as the Food and Drug Administration (FDA).

Biopharmaceutical manufacturing is intricately linked with R&D and relies heavily on extensive scientific expertise and robust infrastructure. Moreover, a thriving innovation ecosystem plays a pivotal role in driving manufacturing advancements. Start-up hubs serve as collaborative spaces for sharing ideas and best practices, while academic institutions contribute valuable talent and resources. These advanced innovation ecosystems often bridge the gap between manufacturing and R&D, fostering synergy for numerous biopharmaceutical companies.

Biopharmaceutical portfolio trends

Biopharmaceutical portfolio trends are shaped by four key market factors, driving the development and adoption of advanced manufacturing technologies. These trends, though interconnected, have distinct implications for the manufacturing sector.

• Complex Medicines on the Rise:

The prevalence of complex medicines has witnessed significant growth, exemplified by the FDA’s annual approval of at least ten large molecules (biologics) over the past five years. With more than 900 biologics currently in development, the demand for their commercial production is expected to increase. These intricate medicines, including vaccines, are derived from living cells and often require specialized manufacturing processes. [Reference]

• Personalized Medicine Emergence

Personalized medicine has gained prominence, with an expanding array of drugs designed to target specific patient populations. The number of customized medications has risen substantially, from a few in 2006 to over 100 in 2013. This emphasis on tailoring treatments to individual patients is driving advancements in biopharmaceutical manufacturing. [Reference]

Other areas of Technology Innovation

In addition to manufacturing technology innovation, there are other areas where advancements are advancing:

• Alternative Techniques in Downstream Bioprocessing

Downstream processing currently lacks significant economies of scale. The production of additional products requires the use of more buffers, tanks, filters, and chromatography equipment.

As a result, companies are actively seeking technological advancements in this area. One special focus of innovation is exploring alternatives to Protein A, a molecule used in the detection and purification of antibodies due to its ability to bind to immunoglobulins. Protein A chromatography is expensive, with high material costs ($12,000–15,000 per liter) and requirements for recycling, cleaning, and validation.

• Drug-Device Combination Products

Combining drugs with medical devices has proven beneficial in enhancing the effectiveness of medicines and promoting patient compliance. While medical device companies traditionally manufactured certain drug-device combination products such as drug-eluting stents, transdermal patches, and inhalers, biopharma companies are now taking on a more prominent role in producing other combination products like pre-filled syringes (PFS), needle-free devices, and sensor-embedded tablets.

Impacts of Manufacturing Advances

The strategies of biopharmaceutical manufacturers influence the evolution of drug portfolios and advancements in manufacturing technologies, particularly in terms of their workforce, collaborations, and choice of locations.

• Driving Workforce development

The expanding biopharmaceutical field requires a skilled workforce, leading to a demand for enhanced capabilities. Education requirements for manufacturing roles have evolved, with an associate’s degree or a combination of relevant studies and certification becoming the norm for biopharma manufacturing operators. Additionally, areas that are diversifying include finance, enterprise resource planning, and supply chain management.

• Increasing collaboration

The pursuit of advanced manufacturing in the biopharmaceutical industry has fostered closer collaboration between biopharma companies and academic engineering institutions, mirroring existing collaborations with educational medical institutions. One particular focus of these partnerships is continuous manufacturing.

For instance, Novartis and MIT formed a five-year, $40 million partnership to develop an experimental continuous production line. This innovative production line, housed in a compact case, significantly reduces manufacturing time for tablets used in treating high blood pressure and heart failure. Successful projects like this encourage further research and exploration of continuous reactions and tools for other drugs. [Reference]

Transforming the entire network

A comprehensive network transformation is underway to revamp site operations across the manufacturing network and various technology platforms and locations. This transformative approach integrates digital practices into work and develops capabilities at all levels of the organization. For more info, visit Gyan Consulting.